Cardiologists around the world grapple with providing implantable devices for heart patients that are affordable. By Michael Lim
IN a recent regional cardiology meeting, a top cardiologist, Dr A, from India remarked that some of the current cardiology guidelines are impractical in countries such as India and should not be followed blindly.
Many of the guidelines for the practice of cardiology which have been drawn up by cardiologists in Europe and the United States are based mainly on trials conducted in Europe and the US. Current guidelines rarely involve cardiologists from Asia, and do not take into account the state of development in these regions.
Dr A quoted the example of Implantable Cardioverter-Defibrillators (ICD). These devices are implantable under the skin and are meant to detect life-threatening heart rhythms and produce an electric shock that is delivered to the heart muscle to attempt to “shock” the rhythm back into a normal one.
More recently, these ICD devices come with combined Cardiac Resynchronisation Therapy (CRT) function which means that they have the additional capability of improving the heart pump function in some patients with heart failure by synchronising the heart’s electrical conduction. These combined devices are called Cardiac Resynchronisation Therapy Defibrillators (CRT-D).
Implantable heart defibrillators
In the latest 2013 joint guidelines on the Appropriate Use Criteria for ICD and CRT from international bodies including the American College of Cardiology Foundation, the Heart Rhythm Society, and the American Heart Association, the indications for the implantation of ICD in patients with underlying heart artery disease have been expanded and are wide-ranging; they include those who have had impaired heart pump function due to an underlying heart disease or a previous heart attack who are known to have or who are at risk of serious heart rhythm abnormalities.
This would mean that a large number of patients with prior heart attacks and impaired heart pump function will meet the criteria for implantation of ICD.
In a 2012 report by a company that provides sourcing services for two large US hospital chains, ICD and CRT devices generally require a replacement every three to seven years. One of the largest manufacturers of these devices issued a Product Performance Report in 2011 which showed that only 40 per cent of these CRT devices released into the market in 2007 were still in service after 4.4 years.
Generally, patients with CRT devices are told that they need a replacement every five years and those with ICD every seven years, but the reality is that they need a replacement within a shorter period.
According to the ICD registry in the US, the approximate procedure and device replacement cost is about US$37,000 excluding physician and anaesthesia fees. As the batteries have a limited life span, patients will require multiple changes during their lifetime. Changes of devices not only involve recurrent cost but also complications of as high as 9 per cent, including death.
In many countries in Asia, the cost of an ICD or CRT device is beyond the reach of a large majority of patients. If guidelines are to be followed, it will put tremendous political pressure on governments to provide this as a standard of care. In the US, over a period of 1993 to 2006, a total of 800,000 ICD devices were implanted and the annual frequency of ICD implantation increases as the indications are broadened.
It is estimated that 10,000 ICD devices are currently being implanted in the US monthly. This works out to about US$370 million every month for device and procedural costs but not including physician costs.
Left ventricular assist devices (LVAD) or artificial hearts provide a new ray of hope for those with heart failure unresponsive to medical treatment and for those who require a heart transplant and will die without a transplant. These are mechanical devices that are implanted into the heart to provide mechanical pumping support to the heart.
Increasingly, patients who have been on the heart transplant list but are not able to survive longer without an imminent heart transplant are given an LVAD device.
These devices can last for years but require a battery pack. The real cost of providing this to patients can amount to US$400,000 for the initial cost and does not take into account recurrent costs.
The American Heart Association recommends the use of LVAD in highly selected patients with refractory end-stage heart failure and an estimated one-year mortality of over 50 per cent with medical therapy.
Are guidelines the gospel truth?
Many patients with heart disease die of heart failure arising from heart rhythm abnormalities. If the guidelines were to be followed and CRT-D devices and/or LVAD were to be provided to these patients, it will reduce deaths but the economic costs will be tremendous.
Based on data from Multicenter Automated Defibrillator Implantation Trial (MADIT II) and other trial data, it was calculated that to prevent one premature death in two years, 18 ICDs have to be implanted.
Given the expanded indications, this raises the concern that many patients who receive ICDs not only do not stand to benefit but are also exposed to unnecessary risks, and this burdens them financially and stresses societal resources.
Approximately 10 to 17 per cent of patients receive an inappropriate ICD electrical shock within the first few years of implantation of the device. In the SCD-HeFT (Sudden Cardiac Death in Heart Failure Trial), the risk of death for those who survived more than 24 hours after a first appropriate ICD shock was three times that of those who did not receive a shock; the shock in some was not only potentially deleterious but also hastened the demise of certain patients.
This is paradoxical as the ICDs that were meant to prolong life could also hasten death. It is also well documented that those who receive ICD electrical shocks have increased anxiety and depression.
Guidelines are exactly what they are literally meant to be – guidelines; they are not meant to be rules or regulations. They are based on trial data that look at statistical significance to determine benefit; it also means that many may not benefit from treatments prescribed in guidelines.
This is where the judgment of the physician is important in determining whether to apply these guidelines. Increasingly, health authorities are using guidelines to judge physicians on the standard of professional care.
If the authorities and the courts choose to discipline physicians on that basis, physicians will be forced to adhere strictly to guidelines. If physicians were to strictly adhere to guidelines on the use of ICD and LVAD devices, and recommend them to patients, many patients will be faced with a huge financial burden and many countries will see their healthcare expenditure balloon exponentially.
Hence, how physicians behave will be determined by whether failure to adhere to US or European guidelines is considered failure of provision of the standard of professional care required of a physician.
As my wise cardiologist Dr A from India said: “If we were to blindly follow these guidelines, the country will go bankrupt.” For the individual patient, it is prudent to have a clear understanding of the pros and cons of expensive potentially life-saving treatments before coming to a decision – not all patients may benefit even if they meet the indications spelt out in the guidelines.